naproxen

Generic: naproxen

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naproxen
Generic Name naproxen
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

naproxen 500 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-436
Product ID 71610-436_59e3892a-f861-4bec-87ee-63bcdc7c1b64
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091416
Listing Expiration 2026-12-31
Marketing Start 2016-07-06

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610436
Hyphenated Format 71610-436

Supplemental Identifiers

RxCUI
198014
UNII
57Y76R9ATQ
NUI
N0000000160 M0001335 N0000175722

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name naproxen (source: ndc)
Generic Name naproxen (source: ndc)
Application Number ANDA091416 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE, PLASTIC (71610-436-53)
  • 90 TABLET in 1 BOTTLE, PLASTIC (71610-436-60)
  • 180 TABLET in 1 BOTTLE, PLASTIC (71610-436-80)
source: ndc

Packages (3)

71610-436-53 60 TABLET in 1 BOTTLE, PLASTIC (71610-436-53) 71610-436-60 90 TABLET in 1 BOTTLE, PLASTIC (71610-436-60) 71610-436-80 180 TABLET in 1 BOTTLE, PLASTIC (71610-436-80)

Ingredients (1)

naproxen (500 mg/1)

Linked Drug Pages (1)

NAPROXEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "59e3892a-f861-4bec-87ee-63bcdc7c1b64", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["57Y76R9ATQ"], "rxcui": ["198014"], "spl_set_id": ["32693390-763b-46dd-b821-65a7bf3c6671"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (71610-436-53)", "package_ndc": "71610-436-53", "marketing_start_date": "20200616"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (71610-436-60)", "package_ndc": "71610-436-60", "marketing_start_date": "20210331"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (71610-436-80)", "package_ndc": "71610-436-80", "marketing_start_date": "20200616"}], "brand_name": "NAPROXEN", "product_id": "71610-436_59e3892a-f861-4bec-87ee-63bcdc7c1b64", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "71610-436", "generic_name": "NAPROXEN", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NAPROXEN", "active_ingredients": [{"name": "NAPROXEN", "strength": "500 mg/1"}], "application_number": "ANDA091416", "marketing_category": "ANDA", "marketing_start_date": "20160706", "listing_expiration_date": "20261231"}